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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01709552
Other study ID # 5K23DA031881-02
Secondary ID
Status Completed
Phase N/A
First received August 10, 2012
Last updated May 21, 2015
Start date March 2012
Est. completion date November 2014

Study information

Verified date May 2015
Source Rhode Island Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to target co-occurring problems of substance use and intimate partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for Substance use and partner Abuse for Females in the Emergency Room). This project will develop and test the computer-based intervention, examining primary outcomes of substance use and utilization of relationship safety resources.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- =18 years of age

- English or Spanish language proficiency sufficient to understand and complete study procedures

- moderate drug use in the prior 3 months (by NM-ASSIST)

- IPV victimization in the prior 6 months (by WAST)

- access to a phone

Exclusion Criteria:

Patients who are:

- intoxicated

- medically unstable as determined by ED staff

- suicidal ideation

- psychosis

- combative

- in police custody

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Computer Intervention
Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.
Control
Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.

Locations

Country Name City State
United States Rhode Island Hospital Department of Emergency Medicine Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in past-month drug use days Drug use based on Timeline Followback. 1 month, 3 month No
Primary Change in use of relationship safety behaviors and referral resources for IPV. Based on Safety Behavior Checklist and Effectiveness in Obtaining Resources scales. 2 weeks, 1 month, 3 months No
Secondary Change in readiness to change drug use. Based on readiness to change rulers. 2 week, 1 month, 3 months No
Secondary Change in readiness to change scale for relationship safety behaviors. Based on readiness to change rulers. 2 weeks, 1 month, 3 months No
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